Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:44 AM
Study NCT ID:
NCT07471893
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, anesthesiologists performing the procedure, and outcome assessors are blinded to group allocation.Group assignment is concealed using a random number table or central randomization system.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, parallel-group, controlled clinical study. Eligible patients will be randomly assigned to two or more groups to compare different timing criteria for endoscope insertion during painless gastroscopy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cough', 'timeFrame': 'From start of endoscope insertion until completion of gastroscopy', 'description': 'Incidence of coughing during endoscope insertion and examination'}, {'measure': 'Body movement', 'timeFrame': 'From start of endoscope insertion until completion of gastroscopy', 'description': 'Incidence of body movement'}, {'measure': 'Hypotension', 'timeFrame': 'From start of endoscope insertion until completion of gastroscopy', 'description': 'Incidence of hypotension'}, {'measure': 'Bradycardia', 'timeFrame': 'From start of endoscope insertion until completion of gastroscopy', 'description': 'Incidence of bradycardia'}, {'measure': 'Hypoxemia', 'timeFrame': 'From start of endoscope insertion until completion of gastroscopy', 'description': 'Incidence of hypoxemia'}], 'secondaryOutcomes': [{'measure': 'Endoscopist satisfaction score', 'timeFrame': 'Immediately after completion of gastroscopy', 'description': 'Endoscopist satisfaction score'}, {'measure': 'PACU discharge time', 'timeFrame': 'From admission to PACU until discharge from PACU', 'description': 'Time to discharge from PACU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Painless gastroscopy, remimazolam, remifentanil'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a prospective clinical study to compare the anesthetic effect of remimazolam combined with remifentanil administered at different time points during gastroscope insertion in patients undergoing painless gastroscopy.The primary outcomes include sedation effect, intraoperative hemodynamic stability, recovery time, and adverse events.', 'detailedDescription': 'This study hypothesized that a dual criterion (absent jaw reflex and stable heart rate) for guiding endoscope insertion is superior to the single eyelash reflex criterion in painless gastroscopy with remimazolam and remifentanil. A short delay after heart rate stabilization may achieve the best balance of safety and efficacy. This randomized controlled trial aims to verify the dual criterion, determine the optimal insertion time window, and establish a standardized clinical protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status Ⅰ/Ⅱ, BMI 18-24kg/m², scheduled for elective diagnostic painless gastroscopy\n\nExclusion Criteria:\n\n* (1) Allergy to remimazolam, remifentanil, BZDs, or opioids; (2) Difficult airway (Mallampati class Ⅲ/Ⅳ,limited mandibular movement, or restricted neck extension);(3)Severe cardiovascular/cerebrovascular/respiratory/hepatic/renal dysfunction;(4)Pregnancy/lactation;(5)Chronic use of sedatives/analgesics/psychotropic drugs; (6) Preoperative pulmonary infection/respiratory failure; (7) Inability to provide informed consent or complete follow-up.'}, 'identificationModule': {'nctId': 'NCT07471893', 'briefTitle': 'Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Huizhou First Hospital'}, 'officialTitle': 'Optimal Insertion Time During Remimazolam-Remifentanil Anesthesia for Painless Gastroscopy: A Single-Center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KYLL-2024-023-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G group', 'description': "The timing point for gastroscope insertion was defined as when the patient's mandible was lifted, no motor response was observed any longer, and the h", 'interventionNames': ['Other: Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C group', 'description': 'The timing point for gastroscope insertion was determined when the corneal reflex was absent.', 'interventionNames': ['Other: Eyelash reflex guided endoscope insertionn']}], 'interventions': [{'name': 'Dual criterion (absent jaw reflex + stable heart rate) guided endoscope insertion', 'type': 'OTHER', 'description': 'Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when jaw reflex is absent and heart rate is stable.', 'armGroupLabels': ['G group']}, {'name': 'Eyelash reflex guided endoscope insertionn', 'type': 'OTHER', 'description': 'Intravenous sedation and analgesia with remimazolam combined with remifentanil. Endoscope insertion is performed when eyelash reflex is absent.', 'armGroupLabels': ['C group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huizhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Huizhou First People's Hospital", 'geoPoint': {'lat': 23.11147, 'lon': 114.41523}}], 'overallOfficials': [{'name': 'Jianhao Zeng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huizhou First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared to protect participant privacy and due to limited data management resources.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huizhou First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology Resident', 'investigatorFullName': 'Jianhao Zeng', 'investigatorAffiliation': 'Huizhou First Hospital'}}}}